Bipolar Study in Adults at Least 18 Years of Age

This study has been completed.

First Received: September 3, 2003 Last Updated: June 25, 2007 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00067938

Purpose

Bipolar study of tolerability, clinical response and patient satisfaction

Condition	Intervention	Phase
Bipolar Disorder	Drug: lamotrigine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of Tolerability, Clinical Response, and Satisfaction in Adult Bipolar I Subjects Optimizing Initiation of Therapy Using Administration of Dermatological Precautions and LAMICTAL Titration Packs

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The primary endpoint will be the rate of rash during 12 weeks. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:

Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores. [ Time Frame: 12 Weeks ]

Estimated Enrollment:	1200
Study Start Date:	August 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of bipolar I disorder.
Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.

Exclusion Criteria:

Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
Presence of untreated thyroid disease.
Patient is actively suicidal or homicidal.
Patient has history of severe hepatic or renal insufficiency.
Patient is currently participating in another clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067938

Show 248 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Chair:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	SCA40917
Study First Received:	September 3, 2003
Last Updated:	June 25, 2007
ClinicalTrials.gov Identifier:	NCT00067938 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

bipolar disorder
lamotrigine

Additional relevant MeSH terms:

Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Affective Disorders, Psychotic

Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2009